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NCT07470788

FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation

Sponsor: Vesalius Cardiovascular Inc.

View on ClinicalTrials.gov

Summary

This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.

Official title: A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, Symptomatic Degenerative Mitral Regurgitation

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03

Completion Date

2032-04

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Degenerative Mitral Regurgitation

Interventions

DEVICE

Transcatheter Mitral Valve Repair

The Vesalius Transcatheter Mitral Valve Repair (TMVr) System is a novel transcatheter device designed to percutaneously deliver an implant to repair the native mitral valve in patients with degenerative mitral regurgitation. The system uses an adjustable ePTFE net to reduce or eliminate mitral regurgitation. The device is delivered via a minimally invasive transcatheter approach, allowing precise positioning and deployment in high-risk patients not suitable for conventional surgery.

Inclusion Criteria: 1. Age ≥ 19 years 2. Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14) 3. New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV) 4. Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation \[1\], as well as patient operative risk assessment by the Heart Team 5. Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging 6. Willing to adhere to study follow-up schedule for up to 5 years 7. Written informed consent provided Exclusion Criteria: 1. Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate) 2. LV ejection fraction \< 30% 3. Active bacterial endocarditis within 60 days of planned index procedure 4. Dialysis-dependent renal insufficiency 5. Body Mass Index (BMI) ≥ 45 kg/m2 6. Previous valvular surgery 7. Previous atrial septal surgery 8. Previous endovascular structural procedure(s) and/or device(s) within 6 months 9. Severe mitral annular calcification (MAC) prohibiting device implantation 10. Severe annulus or leaflet calcification 11. Leaflet perforation 12. Contraindication to anticoagulation / antiplatelet therapy 13. Patients with sensitivity to nickel or contrast media 14. Concomitant severe tricuspid regurgitation 15. Absence of conventional medial and lateral papillary muscle groups 16. Femoral vein cannot accommodate a 29 F catheter 17. Contraindication to Transoesophageal echocardiography (TEE) 18. Life expectancy \<1 year due to non-cardiac comorbidities. 19. Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team 20. Participation in other clinical investigation 21. Pregnant or planning to become pregnant

Locations (1)

St. Paul's Hospital

Vancouver, Canada